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TTHX1114(NM141) in Combination With DWEK/DSO

Phase 2
Waitlist Available
Research Sponsored by Trefoil Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
No Placebo-Only Group

Summary

This trial involves a known treatment given to all participants.

Eligible Conditions
  • Corneal Endothelial Dystrophy
  • Fuchs' Dystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best Corrected Visual Acuity

Side effects data

From 2021 Phase 1 & 2 trial • 22 Patients • NCT04520321
14%
Iritis
14%
Eye irritation
14%
Photophobia
14%
Eye pain
14%
Punctate keratitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle (Placebo)
High-dose
Low Dose
Mid-dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Group 3aExperimental Treatment1 Intervention
Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)
Group II: Group 3 TTHX1114 in combination with DWEK/DSOExperimental Treatment1 Intervention
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
Group III: Group 2 TTHX1114 in combination with DWEK/DSOExperimental Treatment1 Intervention
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
Group IV: Group 1aExperimental Treatment1 Intervention
Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)
Group V: Group 1 DWEK/DSOActive Control1 Intervention
Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTHX1114(NM141)
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Trefoil Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
71 Total Patients Enrolled
Thomas TremblayStudy DirectorTrefoil Therapeutics.com
2 Previous Clinical Trials
49 Total Patients Enrolled
~10 spots leftby Dec 2025
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